Cytori Provides Update in 510(k) Appeal Decision

  Cytori Provides Update in 510(k) Appeal Decision

Business Wire

SAN DIEGO -- March 22, 2013

Cytori Therapeutics (NASDAQ: CYTX) today announced that the United States
Court of Appeals for the District of Columbia Circuit has ruled on the
Company’s conjoined appeals (case no. 11-1268).

The court upheld the FDA’s (Food and Drug Administration) previous
determination that Cytori’s cell processing devices were not substantially
equivalent to the cited predicate devices. Cytori will continue to pursue its
intended pathway to regulatory approval via the PMA (Premarket Approval)
route, such as the active ATHENA clinical trial for refractory heart failure.
Cytori received IDE (Investigational Device Exemption) in January 2012
required to initiate the ATHENA clinical trial.

“This decision reaffirms our primary regulatory pathway in the U.S.,” said
Christopher J. Calhoun, Chief Executive Officer of Cytori. “Our priority
remains unchanged, which is completion of clinical development of our
Celution® System in refractory heart failure under the FDA’s PMA clinical
trial-based pathway for class 3 medical devices. Such a pathway provides the
necessary data for approval, adoption, and reimbursement and will raise an
additional barrier-to-entry for potential competitors who would be required to
pursue the same PMA pathway. As a result, this decision further clarifies the
standard-of-evidence required for the field.”

Cytori has been pursuing parallel pathways to market. One pathway has been to
obtain therapeutic indications, such as those being pursued in our cardiac
development. The other pathway has been to obtain clearance for laboratory
equipment that would provide technology access to researchers, for which
Cytori has achieved approval in Europe and Japan. Cytori appealed the decision
based on a series of prior 510(k) clearances and a 2009 determination by the
FDA, through a formal request for designation by the office of FDA’s
combination products, that Cytori’s cell processing technology would be
regulated as a medical device and not a biologic. The appeal was related to
the subsequent 2011 decision by the FDA to deny the 510(k) clearance for
laboratory versions of our cell processing technology.

Regulatory Overview

The FDA regulates medical devices as class 1, 2, or 3. Typically, class 2
devices require a demonstration of substantial equivalence to a pre-existing
device with limited or no clinical data. Class 3 devices are considered novel
and more complex, thus require clinical data and/or clinical testing under the
PMA pathway.

Cytori and the FDA agree that marketing approval for the Company’s Celution®
System for use in cardiovascular disease and other therapeutic indications
requires a PMA. The appeals rulings announced today relate to the Company’s
separate actions to seek approval for tissue processing systems for use in
banking and research as class 2 medical devices.

About Cytori Therapeutics

Cytori Therapeutics, Inc. is developing cell therapies based on autologous
adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and
repair soft tissue defects. Our scientific data suggest ADRCs improve blood
flow, moderate the inflammatory response and keep tissue at risk of dying
alive. As a result, we believe these cells can be applied across multiple
“ischemic” conditions. These therapies are made available to the physician and
patient at the point-of-care by Cytori’s proprietary technologies and
products, including the Celution® system product family. www.cytori.com

Cautionary Statement Regarding Forward-Looking Statements

This communication includes forward-looking statements regarding events,
trends and business prospects, which may affect our future operating results
and financial position. Such statements including those regarding our expected
enrollment completion date of our Athena trial, are subject to risks and
uncertainties that could cause our actual results and financial position to
differ materially. Some of these risks include clinical and regulatory
uncertainties, risks in the collection and results of clinical data, clinical
outcomes, dependence on third party performance, and other risks and
uncertainties described under the “Risk Factors” in Cytori’s Securities and
Exchange Commission Filings. We assume no responsibility to update or revise
any forward-looking statements to reflect events, trends or circumstances
after the date they are made.

The Celution® System is available in the United States for investigational use
only.

Contact:

Cytori Therapeutics, Inc.
Tom Baker, +1-858-875-5258
tbaker@cytori.com
 
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